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CTRI Number  CTRI/2024/09/073993 [Registered on: 18/09/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on the risk of developing chronic kidney disease in long term diabetes patients of conventional and homoeopathic treatments 
Scientific Title of Study   A Cross sectional analytical study on the risk of developing chronic kidney disease in long term diabetes patients of conventional and homoeopathic treatments 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RAHEENA V 
Designation  Post graduate scholar 
Affiliation  govt homoeopathic medical college Karaparamba 
Address  Department of Practice of medicine govt homoeopathic medical college Karaparamba Kozhikode Kerala 673010 India

Kozhikode
KERALA
673010
India 
Phone  8590334172  
Fax    
Email  raheena06@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abdul Hameed 
Designation  Guide 
Affiliation  govt homoeopathic medical college Karaparamba 
Address  Department of Practice of medicine govt homoeopathic medical college Karaparamba Kozhikode Kerala

Kozhikode
KERALA
673010
India 
Phone  944763227  
Fax    
Email  hameeddr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Abdul Hameed 
Designation  Guide 
Affiliation  govt homoeopathic medical college Karaparamba 
Address  Department of Practice of medicine govt homoeopathic medical college Karaparamba Kozhikode Kerala

Kozhikode
KERALA
673010
India 
Phone  944763227  
Fax    
Email  hameeddr@yahoo.com  
 
Source of Monetary or Material Support  
Govt Homoeopathic medical college , Karaparamba,Kozhikode, Kerala pin: 673010 
 
Primary Sponsor  
Name  Dr Raheena V 
Address  Post graduate scholar Department of practice of medicine Govt Homoeopathic medical college , Karaparamba,Kozhikode, Kerala pin: 673010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raheena V  Govt homoeopathic medical college  Research OP no.9 and OP 3 department of practice of medicine Govt homoeopathic medical college Karaparamba Kozhikode pin:673010 Karaparamba Kozhikode 673010
Kozhikode
KERALA 		 8590334172

raheena06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Medical College,Karaparamba,Kozhikode  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  patients diagnosed with diabetes mellitus for 5 years or more
Subjects fulfilling the American Diabetes Association criteria for diabetes mellitus 
 
ExclusionCriteria 
Details  patients with history of receiving both conventional and homoeopathic anti diabetic treatments together
Pregnant women
patients with severe systemic illness
patients with other causes of renal impairment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Calculate odds ratio in risk of developing CKD between patients taking conventional and homoeopathic anti diabetic treatments  only base line data collected at a single time 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [raheena06@gmail.com].

  6. For how long will this data be available start date provided 27-10-2025 and end date provided 22-06-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study compares the risk of developing chronic kidney disease (CKD) in long-term diabetes patients treated with either conventional or homoeopathic therapies. Using a cross-sectional analytical design, the research evaluates kidney function markers in both groups to determine the effectiveness of each treatment in preventing or delaying CKD progression. The study aims to provide insights into the relative benefits or limitations of homoeopathic treatment compared to standard conventional care for diabetes-related kidney complications.

 
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